Lovastatin
LOVASTATIN TABLETS USP10 mg, 20 mg and 40 mgRx only
Approved
Approval ID
df7ddf4f-d569-431e-81f1-9129d7043150
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2023
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lovastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-467
Application NumberANDA078296
Product Classification
M
Marketing Category
C73584
G
Generic Name
lovastatin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (9)
LOVASTATINActive
Quantity: 10 mg in 1 1
Code: 9LHU78OQFD
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
lovastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-468
Application NumberANDA078296
Product Classification
M
Marketing Category
C73584
G
Generic Name
lovastatin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (9)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LOVASTATINActive
Quantity: 20 mg in 1 1
Code: 9LHU78OQFD
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
lovastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68180-469
Application NumberANDA078296
Product Classification
M
Marketing Category
C73584
G
Generic Name
lovastatin
Product Specifications
Route of AdministrationORAL
Effective DateNovember 30, 2023
FDA Product Classification
INGREDIENTS (9)
LOVASTATINActive
Quantity: 40 mg in 1 1
Code: 9LHU78OQFD
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 11/20/2018
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 68180-467-07
LOVASTATIN TABLETS USP
10 mg
Rx only
Bottle of 60 Tablets
NDC 68180-468-07
LOVASTATIN TABLETS USP
20 mg
Rx only
Bottle of 60 Tablets
NDC 68180-469-07
LOVASTATIN TABLETS USP
40 mg
Rx only
Bottle of 60 Tablets
